Efficacy of 12-week Daytime Restricted Eating on Hepatic Steatosis of Obesity

NCT07378072 | Not Yet Recruiting

• 1 other identifier: RC21_0569
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 9

Brief Summary

The objective of this study is to demonstrate that an \< or equal to 8-hour time-restricted eating (i.e., fasting for at least 16 hours every day), not focusing on reducing caloric intake, reduces intra-hepatic fat in patients with obesity and Metabolic dysfunction-Associated Steatotic liver Disease (MASLD).

Conditions

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

Keywords

Time-restricted eating; Obesity; MASLD; circadian rhythms

Outcome Measures

Primary Outcomes (1)

• Liver fat content quantified by Magnetic Resonance Imaging Proton Density Fat Fraction

  Liver fat content quantified Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) before randomization and then at 12 weeks post randomization

  12 weeks post randomization

Secondary Outcomes (36)

• Average lenght of the eating period per 24 hours

  12 weeks post randomization

• Liver steatosis and Stiffness as assessed by the Fibroscan

  12 weeks post randomization

• Hepatic outcomes evaluated through aspartates aminotransferases (ASAT) blood level before randomization and at 12 weeks post randomization.

  12 weeks post randomization

• Physical activity level measured by accelerometry with a watch accelerometer

  12 weeks post randomization

• Anthropometric outcomes assessed by body weight.

  12 weeks post randomization

Study Arms (2)

Time Restricted Eating

EXPERIMENTAL

Coaching of the patient by a dietetician for reduction of time of daily food intake to a window of 8 hours per day or less and thus increase of daily fasting to at least 16 hours, in addition to usual dietary counselling to achieve a balanced diet (no calorie restriction) and increase physicial activity as recommended (current guidelines).

Behavioral: Time Restricted Eating

Usual care only

ACTIVE COMPARATOR

Only usual care: usual dietary counselling to achieve a balanced diet (no calorie restriction) and increase physicial activity as recommended (current guidelines).

Behavioral: Usual care only

Interventions

Time Restricted Eating BEHAVIORAL

Coaching of the patient by a dietetician for reduction of time of daily food intake to a window of 8 hours per day or less and thus increase of daily fasting to at least 16 hours, in addition to usual dietary counselling to achieve a balanced diet (no calorie restriction) and increase physicial activity as recommended (current guidelines).

Time Restricted Eating

Usual care only BEHAVIORAL

Usual care: dietary counselling to achieve a balanced diet (no calorie restriction) and increase physicial activity as recommended (current guidelines).

Usual care only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) between 30.0 and 49.9 kg/m2
• Age between 18 and 65 years (limits included)
• Sedentary (light-intensity physical activity less than 1 hour per week) or moderately active (moderate exercise 1 to 2 hours per week). Self-declared criteria.
• Weight stable for at least 3 months prior to the beginning of the study (gain or loss \<4 kg). Self-declared criteria.
• Able to give written informed consent
• Self-reported eating interval \> 12 hours per day
• Subject who owns a smartphone with access to the internet, and agrees to use it in the study
• Affiliation with French social security system or beneficiary from such system
• Fibroscan® Controlled Attenuation Parameter (CAP) \> 300 dB/ms
• Hepatitis B and C serologies negative (or showing past-infection or protective immunization)

You may not qualify if:

• Alcohol intake \> 20 g/day
• Night-shift workers or rotating shift workers
• Smoking
• Patient with diabetes if HbA1c not at target (\<7%) and/or using a non-authorized medication)
• Chronic liver disease other than MASLD
• Severe hepatic disease (cirrhosis, hepatocellular carcinoma)
• Severe cardiac disease (Chronic heart failure classified as being in New York Heart Association (NYHA) Class III or IV)
• Severe Kidney disease with CKD-EPI\<30 mL/min/1,73m2
• Initiation of hormonal treatment during the study period
• Medications affecting weight or energy balance
• Magnetic Resonance Imaging (MRI) not possible due to patient's anthropometric characteristics. Any of the following:
• abdominal and/or thoracic circumference with arms greater than 200 cm
• Sagittal diameter (or abdominal height, i.e. the distance between the dorsum and the apex of the abdomen, which was measured in the supine position at the midpoint between the iliac crest and the last rib) over 70 cm
• body weight over 160 kg
• History of severe eating disorders: Binge Eating Disorder, Bulimia Nervosa; Night eating syndrome

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (9)

CHU Angers

Angers, 49993, France

Location

CHU Bordeaux

Bordeaux, 33404, France

Location

CHU Dijon-Bourgogne

Dijon, 21000, France

Location

CHU Lyon

Lyon, 69495, France

Location

CHU Marseille

Marseille, 13000, France

Location

CHU Montpellier

Montpellier, 34000, France

Location

CHU Nantes

Nantes, 44093, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

CHU Rennes

Rennes, 35000, France

Location

MeSH Terms

Conditions

Intermittent Fasting; Obesity

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

David JACOBI, MD

CONTACT

02 53 48 27 01; david.jacobi@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 30, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

FR (9)